Injections Recalled for Possible Glass Particulate Matter

The potential for the presence of glass particulate matter in the products has prompted Hospira Inc., a Pfizer company, to recall 3 lots containing sodium bicarbonate injections and atropine sulfate injections. According to the January 24, 2024, US Food and Drug Administration (FDA) Enforcement Report, the recalls have been designated Class I, which warns use of the affected injections could cause serious adverse health consequences or death.

“Should a patient receive an injectable product containing glass particulate matter as a result of this issue, the patient may experience serious adverse events,” Hospira stated in a December 21, 2023, announcement. “Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events.”

The recall includes the following products, which were distributed throughout the United States and Puerto Rico between March 14, 2023, and June 29, 2023:

• 4.2% sodium bicarbonate injection, 5 mEq/10 mL (0.5 mEq/mL), 1 10-mL Abboject glass syringe per carton (carton NDC 0409-5534-24, case NDC 0409-5534-14), from lot GX1542 (Exp. 1/1/25);
• 8.4% sodium bicarbonate injection, 50 mEq/50 mL (1 mEq/mL), 1 50-mL Lifeshield Abboject glass syringe per carton (carton NDC 0409-6637-24, case NDC 0409-6637-14), from lot HA7295 (Exp. 3/1/25); and
• atropine sulfate injection, 1 mg/10 mL (0.1 mg/mL), 1 10-mL Lifeshield Abboject glass syringe per carton (carton NDC 0409-4911-11, case NDC 0409-4911-34), from lot GY2496 (Exp. 2/1/25).

Pfizer Inc. voluntarily initiated the recalls December 21, 2023. On January 17, 2024, the FDA designated them Class I.

Sodium bicarbonate injection is an electrolyte replenisher and systemic alkalizer with multiple indications. Atropine sulfate injection is indicated for the temporary blockade of severe or life-threatening muscarinic effects and to treat bradyasystolic cardiac arrest.